EverFlo EverFlo w/Oxygen Percentage Indicator, 230V, IT, CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959032590), received between Nov 15, 2023 and Apr 25, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Smoking; Smoking

  THE MANUFACTURER WAS CONTACTED ON EVERFLO DEVICE THAT CAME BACK FROM REPAIRS A WEEK AGO, BUT IT SMELLS LIKE SMOKE WHEN IT IS IN OPERATION. NO MEDICAL INTERVENTION WAS SPECIFIED AS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908266 ↗
• MalfunctionJan 21, 2025Thermal Decomposition of Device; Gas Output Problem; Leak/Splash; Pressure Problem; Insufficient Device Problem Information; Thermal Decomposition of Device; Gas Output Problem; Leak/Splash; Pressure Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING NOT COMPLIANCE PRESSURE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND COMPRESSOR BURN. ADDITIONALLY, FLOWMETER IS CRACK, SIEVES IS CLOGGED, O2 BODY AND VALVES IS DEFECTIVE. THE CUSTOMER COMPLAINT WAS REPRODUCED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201026 ↗
• MalfunctionNov 15, 2023Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED AN ALLEGATION THAT THE BODY WORK OF THE EVERFLO DEVICE IS DEFORMED DUE TO OVERHEATING. NO ALLEGATIONS OF PATIENT HARM, SERIOUS INJURY, OR MEDICAL INTERVENTION ARE SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145883 ↗